title: Design and methodology of the NorthStar Study: NT-proBNP stratified follow-up in outpatient heart failure clinics -- a randomized Danish multicenter study.
abstract: BACKGROUND
  Randomized clinical trials have shown that newly discharged and symptomatic patients with chronic heart failure (CHF) benefit from follow-up in a specialized heart failure clinic (HFC). Clinical stable and educated patients are usually discharged from the HFC when on optimal therapy. It is unknown if risk stratification using natriuretic peptides could identify patients who would benefit from longer-term follow-up. Furthermore, data on the use of natriuretic peptides for monitoring of stable patients with CHF are sparse.
  
  
  OBJECTIVE
  The aims of this study are to test the hypothesis that clinical stable, educated, and medical optimized patients with CHF with N-terminal pro-brain natriuretic peptide (NT-proBNP) levels > or = 1,000 pg/mL benefit from long-term follow-up in an HFC and to assess the efficacy of NT-proBNP monitoring.
  
  
  METHODS
  A total of 1,250 clinically stable, medically optimized, and educated patients with CHF will be enrolled from 18 HFCs in Denmark. The patients will be randomized to treatment in general practice, to a standard follow-up program in the HFC, or to NT-proBNP monitoring in the HFC. The patients will be followed for 30 months (median).
  
  
  RESULTS
  Data will be collected from 2006 to 2009. At present (March 2008), 720 patients are randomized. Results expect to be presented in the second half of 2010.
  
  
  CONCLUSIONS
  This article outlines the design of the NorthStar study. If our hypotheses are confirmed, the results will help cardiologists and nurses in HFCs to identify patients who may benefit from long-term follow-up. Our results may also indicate whether patients with CHF will benefit from adding serial NT-proBNP measurements to usual clinical monitoring.
authors.affiliation: The Danish Heart Failure Clinics Network, C/O Frederiksberg University Hospital, Frederiksberg, Denmark. m.schou@dadlnet.dk
authors.forename: Morten
authors.initials: M
authors.lastname: Schou
authors.forename: Finn
authors.initials: F
authors.lastname: Gustafsson
authors.forename: Lars
authors.initials: L
authors.lastname: Videbaek
authors.forename: John
authors.initials: J
authors.lastname: Markenvard
authors.forename: Hans
authors.initials: H
authors.lastname: Ulriksen
authors.forename: Henrik
authors.initials: H
authors.lastname: Ryde
authors.forename: Jens C H
authors.initials: JC
authors.lastname: Jensen
authors.forename: Tonny
authors.initials: T
authors.lastname: Nielsen
authors.forename: Anne S
authors.initials: AS
authors.lastname: Knudsen
authors.forename: Christian D
authors.initials: CD
authors.lastname: Tuxen
authors.forename: Jens
authors.initials: J
authors.lastname: Handberg
authors.forename: Per J
authors.initials: PJ
authors.lastname: Sørensen
authors.forename: Geert
authors.initials: G
authors.lastname: Espersen
authors.forename: Søren
authors.initials: S
authors.lastname: Lind-Rasmussen
authors.forename: Niels
authors.initials: N
authors.lastname: Keller
authors.forename: Kenneth
authors.initials: K
authors.lastname: Egstrup
authors.forename: Olav W
authors.initials: OW
authors.lastname: Nielsen
authors.forename: Jawdat
authors.initials: J
authors.lastname: Abdulla
authors.forename: Ole
authors.initials: O
authors.lastname: Nyvad
authors.forename: Jens
authors.initials: J
authors.lastname: Toft
authors.forename: Per R
authors.initials: PR
authors.lastname: Hildebrandt
mesh_terms: D000553:Ambulatory Care / Q000379:methods*; D000554:Ambulatory Care Facilities; D003266:Continuity of Patient Care; D003718:Denmark; D006333:Heart Failure / Q000097:blood / Q000628:therapy*; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods*; D015337:Multicenter Studies as Topic; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
chemical_list: D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain